IRB Number:

355-06

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The research staff is collecting clinical and family histories, blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, including pancreatic cancer and melanoma. This will help the researchers to learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. These future studies could involve searching for changes in the genetic material (DNA) taken from blood and/or tissue. The information and samples will be used in future research studies.

Some of the future research studies could involve genetic testing. Because the genetic tests are not used for regular medical care, the patient will not be told the results of the test(s). The test results will not be put in the patient's medical record either.

Who is Eligible to Participate in the Study?

(#1 through 3 and #4 or #5 must be checked to be eligible):

1. Participant is past his/her 18th birthday
2. Participant is mentally competent and able to provide informed consent
3. Participant is able to understand and read English
4. At least two blood relatives with pancreatic cancer (both must be related)
5. At least one blood relative with pancreatic cancer and one blood relative with melanoma (both must be related)

What is Involved With this Study?

1. Participants will be asked to donate four tablespoons of blood for this familial data and tissue registry.

2. The research staff may ask to collect a sample of cells from the participant's mouth by mouthwash or small brush for future research studies.

3. Participants will be asked to sign a medical release allowing us to review their medical record and/or request a small piece of any leftover tissue they may have had taken from a previous surgery to be used for future research studies.

4. A portion of the participant's blood and/or tissue sample(s) may be sent to research laboratories outside of Mayo Clinic. If their sample(s) are sent to outside researchers, their name will not be linked with the sample(s). No portion of the sample(s) will be kept by the outside researchers beyond the length of the study.

5. Participants will be given two surveys to fill out: one regarding family, health, and environmental exposure histories, and one regarding their opinion on cancer and cancer screening. These surveys will take about one and one half hours to complete.

6. Participants will be asked to complete a follow up survey one year after they enroll in the study. This survey will take about 15 minutes to complete.

7. If participants indicate a family history of pancreatic cancer and/or melanoma, the research staff may ask the participant to provide names and addresses of relatives of interest so that the researchers may approach those relatives for participation in this data and tissue registry.

How long will the Study run?

Participation in this familial data and tissue registry will last approximately one year, however, the participant's data and samples will be stored indefinitely. No visits to Mayo Clinic are necessary for participation in this familial data and tissue registry.

Sponsor(s): National Institutes of Health (NIH)

Study Activation/Registration Date: 08/01/2002

IRB Review and Approval Date: 03/13/2008

Study Type: Familial Tissue and Data Registry

Projected Accrual: The plan is to have up to 2,000 family members of pancreatic cancer patients participate at Mayo Clinic.

Costs of Study:Participants will not need to pay for any procedures which are done just for this familial data and tissue registry. They will not be charged extra for the collection of blood or buccal (cheek) cells. If they do incur any expenses related to the collection of blood or buccal (cheek) cells, the participant will be reimbursed for those expenses. The only other procedures that this study involves are possible collection of any leftover tissue specimens, which were done as part of their health care.

Principal Investigator: Gloria M. Petersen, PhD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 10/02/2009